September 26, 2018

CER

Completing a Clinical Evaluation Report (CER) is like learning a new skill. Initially it can seem daunting and difficult, but once you learn a sensible way to execute it, it becomes much easier. Fang Consulting is here to support your company on their path to producing a CER. Contact us with your questions regarding your CER needs.

WHAT IS A CER?

A CER is an assessment of the data gathered, either through a literary analysis or through clinical trials, pertaining to the safety of your device in its intended use.

Stages of a CER are as follows:

  • Determine the Scope of Work
  • Find Clinical Data Using:
    • Literary Analysis
    • Clinical Experience
    • Clinical Investigation
  • Evaluate Data to Determine its Relevance, Quality, and Significance
  • Analyze the Data to Find its Strengths and Conclusions
  • Determine Whether Findings are Significant and Sufficient
  • Produce the CER

A CER is required when attempting to market devices, including Class I devices, globally

Options for preparing a CER (according to MEDDEV 2.7.1 Rev. 4)

  • Perform a Clinical Study and Summarize the Results
  • Perform a Literary Study of Relevant Clinical Literature
  • A Combination of Both

Our team will help you review the data that is relevant to your device by working with data gathered from clinical trials or through a literature review to evaluate the safety of your device in its intended use.